Medical Procedure Kits Correction: Medline Industries, LP Issues Correction for Medline Procedure Kits Containing Medtronic Aortic Root Cannula due to Potential Excess Material in Male Luers

This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.

Affected Product

Product Names: Medline Kits Containing Medtronic Aortic Root Cannula, labeled as follows:

CABG OPNHRT SALEM HSP
CARDIAC CABG
CARDIAC PACK
DR DANIELSON AC PACK
HEART BASIN PACK-LF
KARAS OH COMPONENT PACK
OPEN HEART ADULT PART 1 CDS
OPEN HEART B PACK-LF
OPEN HEART PACK
ZEESHAN OPEN HEART
TOL DR RIORDAN PACK
HEART BASIN PACK-LF
CPB ADJUNCT PACK
DR. CRESCENZO PACK
PK CUST CV A&B CABRINI CO
TOL DR RIORDAN PACK
TOL DR. CRESCENZO PACK
TOL DR. MORONT PACK

Full List of Affected Devices

Product Name	UDI	Lot Numbers
CABG OPNHRT S HSP	10195327449650	23IBH906, 24EBC446, 24FMC989, 24GME639
CABG OPNHRT S HSP	10198459089503	24KMB217, 25AMG162
CARDIAC CABG	10195327490362	23LBV500, 24DBS178, 24EBK724, 24FBL825
CARDIAC PACK	10195327490355	24CBN830, 24DBS177
DR D AC PACK	10195327298258	23HBD834, 23IBF066
HEART BASIN PACK-LF	10195327047573	22GMD767, 22JMD290, 23GMC713, 23IMA561, 23KMC902
K OH COMPONENT PACK	10195327659684	24EBT996, 24IBR766, 24KBJ595, 24LBQ493
OPEN HEART ADULT PART 1 CDS	10195327034726	24CBG813
OPEN HEART B PACK-LF	10195327206383	22IMH938, 22KMC295, 23AMD800, 23DME198, 23GMD603, 23GMI093, 23HMG457, 23IMG457, 23KMJ484, 24AMG704, 24AMI684, 24BMG042, 24GMA506, 24GMA897
OPEN HEART PACK	10889942934164	23JBD049
Z OPEN HEART	10195327659882	24EBT606, 24IBE093, 24JBV568, 24KBR945
TOL DR R PACK	10195327166304	22GBL197, 22JBG283
TOL DR R PACK	10195327273484	23ABO787, 23EBT153, 23HBB950
TOL DR R PACK	10195327503390	24CBL126, 24EBV315, 24EBW136
HEART BASIN PACK-LF	10195327563561	24BMB798, 24DMH381, 24EMF949, 24GMF161, 24IMB237
TOL DR R PACK	10198459054242	24IBV027
TOL DR. C PACK	10195327176914	22HBX339
TOL DR. CRESCENZO PACK	10195327273750	22LBC389, 23EBQ439, 23HBG138
TOL DR. C PACK	10195327513818	23KBS878, 24CBB191, 24EBD828
TOL DR. C PACK	10198459054259	24FBO426, 24HBP282, 24JBL545, 24LBR173
TOL DR. M PACK	10195327513825	23KBC932, 24CBP602, 24EBV519
TOL DR. M PACK	10198459054266	24GBI558, 24GBX898, 24IBE173, 24IBE173A, 25ABG352

What to Do

On February 21, 2025, Medline Industries, LP sent all affected customers an Immediate Action Required Medical Device Recall notice recommending the following actions:

Complete the response form, listing all affected product in inventory.
- Complete the form even if there is no affected product in inventory.
Once completed, customers will receive labels for affected inventory that instruct staff to remove the recalled component before using the kit.
Notify any companies or individuals who may have received affected products.

Reason for Correction

Medline Industries LP is correcting certain lots of their medical procedure kits containing recalled Medtronic Aortic Root Cannulas due to the potential for excess material in the male luer. Medline is providing a sticker to attach to the procedure kits notifying the user not to use the aortic root cannula within the procedure kit and to use an aortic root cannula from another supplier.

The use of the affected products may cause serious adverse health consequences, including procedure delay, neurological deficits/stroke (reversable and irreversible) and death.

At this time, Medline Industries LP has reported no serious injuries or deaths related to this issue.

Device Use

Medline medical procedure kits containing Medtronic Aortic Root Cannulas are convenience kits used for various medical procedures. The Medtronic Aortic Root Cannula in the kit is used for six hours or less during surgery with the heart-and-lung machine (cardiopulmonary bypass). The cannula may also be used to remove air from the major artery (aorta) when a bypass procedure is finished. 

Contact Information

Customers in the U.S. with questions about this recall should contact the Recall Department at 866-359-1704 or recalls@medline.com.

Additional FDA Resources (listed in order of most to least recent):

Related FDA recall classification summaries:
- 03/31/2025: Vascular Cannula Recall: Medtronic Removes Aortic Root Cannula Due to Unexpected Loose Material in the Male Luer
FDA’s Enforcement Report
Medical Device Recall Database

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.